Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLouisiana State University Health Sciences Center Shreveport
About this trial
This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.
Eligibility criteria
Qualifiers
Male or female subjects between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and Other Psychotic Disorders.
A BPRS score > 35 at the screening visit.
An AES-C score > 32 at the screening visit.
If the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. A therapeutic regimen may include medication, supplements, and/or probiotics.
Disqualifiers
A BPRS score < 35 at the screening visit.
An AES-C score < 32 at the screening visit.
Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.
Are currently taking more than one antipsychotic medication.
Trial design
Treatments tested in this trial
- Lumateperone 42 mg
- Risperidone 2 mg
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov